DSD Models at South Africa Sentinel Sites

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

15520 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Many countries in sub-Saharan Africa are rapidly scaling up "differentiated service delivery" (DSD) models for HIV treatment to improve the quality of care, increase access, reduce costs, and support the continued expansion and sustainability of antiretroviral therapy (ART) programs. Although there is some published evidence about the health outcomes of patients in DSD models, little is known about their impacts on healthcare providers' job satisfaction, patients' quality of life, costs to providers or patients, or how DSD models affect resource allocation at the facility level.

SENTINEL is a multi-year observational study that will collect detailed data about DSD models for ART delivery and related services from 12 healthcare facilities in Malawi, 24 in South Africa, and 12 in Zambia. The first round of SENTINEL included a patient survey, provider survey, provider time-and-motion observations, and facility resource use inventory. A survey of clients testing for HIV and a supplement to the facility resource use component to describe service delivery integration will be added for the second round. The patient survey will ask up to 10 patients enrolled in each DSD model at each study site about their experiences in HIV care and in DSD models, costs incurred seeking treatment, and preferences for HIV service delivery. The provider survey will ask up to 10 providers per site about the impact of DSD models on their positions and clinics. The time-and-motion component will directly observe the time use of a sample of providers implementing DSD models. Finally, the resource utilization component will collect facility-level data about DSD model availability and enrollment and the human and other resources needed to implement them. SENTINEL is planned to include at least four approximately annual rounds of data collection between 2021 and 2025.

As national DSD programs for HIV treatment mature, it is important to understand how individual healthcare facilities are interpreting and implementing national guidelines and how healthcare workers and clients are adapting to new models of service delivery. SENTINEL will help policy makers and program managers understand the benefits and costs of differentiated service delivery and improve resource allocation going forward.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

DSD Models at Zambia Sentinel Sites (SENTINEL 2)

NCT05902572

HIV

ACTIVE_NOT_RECRUITING

DSD Models at Malawi Sentinel Sites (SENTINEL 2-Malawi)

NCT05901727

HIV

ACTIVE_NOT_RECRUITING

Differentiated Service Delivery for Pregnant and Postpartum Women Living With HIV and Their Infants

NCT06629753

Hiv Transmission Vertical Viremia +2 more

ACTIVE_NOT_RECRUITING NA

Universal Test and Connect for HIV Service Delivery in South Africa

NCT06408142

Human Immunodeficiency Virus Pre-Exposure Prophylaxis Emergency Department +1 more

RECRUITING

Experimental Analysis of HIV Risk Assessment Reactivity in South African Clinics

NCT01580657

HIV Prevention and Assessment Reactivity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

* Patient-facing or patient-supporting service provider at the study site (patient-supporting providers include data clerks, pharmacists, etc.)
* Directly or indirectly involved in the site's implementation of ART and DSD models
* Employed in current role at the study site for at least six months
* Provides written informed consent to participate

* Direct or indirect service provider at the study site (indirect providers include supervisors, technical advisors, etc.)
* Directly or indirectly involved in the site's implementation of ART and DSD models
* Employed in current role at the study site for at least six months
* Provides written informed consent to participate.

* Living with HIV and on ART for at least six months at the study site
* ≥ 18 years old (18 and older considered adult for research purposes in South Africa)
* Enrolled in a specified model of care (including conventional care) up to the target number of participants for that model and have received at least one medication refill under this model
* Provide written informed consent to participate.

* Undergoing HIV testing at the study site or other testing site within the catchment area
* ≥ 18 years old (18 and older considered adult for research purposes in South Africa)
* Provide written informed consent to participate.

Exclusion Criteria

● None.

● None.

* Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
* Not physically, mentally, or emotionally able to participate in the study, in the opinion of the investigators or study staff.
* Unwilling to take the time required to complete the questionnaire on the day of consent.

* Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
* Not physically, mentally, or emotionally able to participate in the study, in the opinion of the investigators or study staff.
* Unwilling to take the time required to complete the questionnaire on the day of consent.

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No